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The Gianturco-Roehm Bird's Nest® Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

1. Pulmonary thromboembolism when anticoagulants are contraindicated;
2. Failure of anticoagulant therapy in thromboembolic diseases;
3. Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced;
4. Prophylactically in patients with chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

The Bird's Nest® Vena Cava Filter is a permanent cardiovascular intravascular filter intended for percutaneous insertion into the inferior vena cava positioned below the renal veins and above the iliac veins. The Bird's Nest® Vena Cava Filter utilizes a fine-wire stainless steel multiplane filtering system. The Bird's Nest® Vena Cava Filter is placed via standard percutaneous entry (Seldinger) technique with fluoroscopic control. Access sites include both left and right femoral, and left and right internal jugular veins. The 11.0 French delivery catheters are available in a 45 cm length for femoral vein approach and a 75 cm length for jugular vein approach. The Bird's Nest® Vena Cava Filter is designed for use in vena cava measuring up to 40 mm in diameter. Caval measurements should be performed prior to filter insertion, and care should be taken to ensure proper strut fixation. The basic function of the filter relies upon shape memory properties of the stainless steel wire which is used for its construction. Four strands of 0.18 mm stainless steel surgical wire, each 25 cm long before forming, are shaped to have 15-20 fine wave bends formed into each wire. Two pairs of hooks, one pair proximal and one pair distal, hold the filter in position. The pairs of hooks are attached to each end of the four wire strands by junction points. The hooks spring out of the catheter and engage the vessel wall. The hooks and the lateral pressure exerted by the preformed curved wires fix the device securely into the vessel wall.

The provided text describes a 510(k) summary for the Gianturco-Roehm Bird's Nest® Vena Cava Filter. It's important to note that a 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical studies demonstrating novel performance criteria with statistical rigor as seen with new drug applications or software as a medical device (SaMD) clearances.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and conformance testing demonstrating that the modified device (specifically, the introducer system and its tip) maintains the safety and effectiveness of the predicate device regarding its physical performance and biocompatibility. There is no mention of a clinical efficacy study with human subjects, AI components, or complex ground truth establishment for this type of device.

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." Specific quantitative acceptance criteria (e.g., "tensile strength must be > X N") and their corresponding measured values are not provided in this 510(k) summary, as is typical for public summaries of this nature.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the provided summary for any of the tests (Tensile, Deployment, Packaging, Bioburden/Residual/Endotoxin). These tests are typically performed on a statistically significant number of manufactured units or relevant components, but the exact numbers are not disclosed here.
• Data Provenance: The tests were conducted internally by Cook Incorporated as part of their design and manufacturing quality assurance processes. The data is prospective, generated specifically for this submission to assess the modified device's performance. Country of origin for data generation is within Cook Incorporated's testing facilities (likely in the USA, as the company is based in Bloomington, IN, USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of "ground truth" establishment in the context of expert review for this device. The tests mentioned (tensile, deployment, packaging, bioburden) are engineering and laboratory tests with objective, measurable outcomes against pre-defined specifications, not subjective interpretations requiring expert consensus like imaging studies.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are objective engineering and laboratory evaluations, not subjective clinical assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or software that involves human interpretation, which is not the nature of this physical medical device modification.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical medical implant (vena cava filter) and does not involve an algorithm or AI functionality that would necessitate standalone performance testing in this manner.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed (Tensile Testing, Deployment Testing, Packaging Design Validation, Bioburden, Residual, and Endotoxin Testing) is based on engineering specifications, established industry standards, and regulatory requirements for the performance and safety of medical devices. For example, tensile strength would be compared against a material specification, and bioburden levels against sterilization standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.

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